Gelband H
Health Technology Consulting, 321 Lincoln Avenue, Takoma Park, Maryland 20912, USA.
Cochrane Database Syst Rev. 2000;1999(2):CD001362. doi: 10.1002/14651858.CD001362.
WHO recommends 6 months of treatment in TB programmes.
The purpose of this review is to assess the effects of regimens lasting less than 6 months compared with longer regimens in the treatment of active TB.
Search strategy: MEDLINE 1955-, Cochrane Infectious Diseases Trials Register, existing reviews, and researchers in the field. Date of the most recent search: January 1999.
Randomized trials comparing two or more TB drug regimens, in which at least one regimen was <6 months and it was compared with at least one regimen that lasted longer, in any patients with active TB.
One reviewer extracted data and assessed trial quality.
Seven trials with a total of 9 comparisons of <6 months (range: 2-5 months) versus longer treatment were included. About 2200 patients were in the shorter regimens and about 1900 in the longer regimens (the same comparison groups were used for more than one shorter regimen, in two studies). Relapse rates were consistently higher after shorter duration treatment regimens, regardless of the comparison made, though they were all relatively low. Results were significantly better in the longer groups in the meta-analyses of 2, 3, and 4 months of treatment vs longer treatment (Peto OR = 6.1 [95%CI 2.19,17.01], 3.67 [2.42,5.58], 3.64 [1.71,7. 75] but not in the single trial of 5 vs. 7 months (Peto OR = 2.24 [0. 90,5.59]. Relapse rates after longer (comparison) regimens ranged from 0-7% at one year (or more), and in the shorter treatment arms, they ranged from 1-9% in 8 trials, and18% relapsed in the one remaining. There was little or no difference in the rates of adverse reactions or toxicity requiring a change of regimen or discontinuation of treatment. The "sterilizing efficacy" at the end of treatment varied little among treatments, providing no predictive value for relapse rates. Few or no deaths were reported in the individual trials, and in no case did enough deaths occur for a comparison of short vs. long regimens.
REVIEWER'S CONCLUSIONS: Longer periods of treatment (at least up to 6 months) result in higher success rates in patients with active TB, but the differences are small. Under field conditions, where adherence to treatment is a big problem, and shorter regimens might improve adherence, these differences may not be evident. A comparison of <6 months vs. 6 months of treatment under programme conditions would be needed to determine this.
世界卫生组织在结核病防治规划中推荐6个月的治疗疗程。
本综述旨在评估与较长疗程相比，疗程少于6个月的治疗方案在治疗活动性结核病中的效果。
检索策略：MEDLINE（1955年起）、Cochrane传染病试验注册库、现有综述以及该领域的研究人员。最近一次检索日期：1999年1月。
随机试验，比较两种或更多种结核病药物治疗方案，其中至少一种疗程<6个月，并与至少一种疗程更长的方案进行比较，受试对象为任何活动性结核病患者。
由一位审阅者提取数据并评估试验质量。
纳入了7项试验，共9次比较疗程<6个月（范围：2 - 5个月）与较长疗程的治疗。较短疗程组约有2200例患者，较长疗程组约有1900例患者（在两项研究中，相同的比较组用于一种以上较短疗程）。无论进行何种比较，较短疗程治疗方案后的复发率始终较高，尽管均相对较低。在治疗2、3和4个月与较长疗程的荟萃分析中，较长疗程组的结果显著更好（Peto比值比=6.1 [95%置信区间2.19,17.01]、3.67 [2.42,5.58]、3.64 [1.71,7.75]），但在5个月与7个月的单项试验中并非如此（Peto比值比=2.24 [0.90,5.59]）。较长（对照）疗程后一年（或更长时间）的复发率为0 - 7%，在较短治疗组中，8项试验的复发率为1 - 9%，剩余一项试验中有18%的患者复发。在需要改变治疗方案或停药的不良反应或毒性发生率方面，几乎没有差异。治疗结束时的“杀菌效力”在各治疗组之间差异不大，对复发率没有预测价值。单项试验中报告的死亡病例很少或没有，在任何情况下，死亡病例数都不足以进行短疗程与长疗程的比较。
较长疗程（至少长达6个月）治疗活动性结核病患者的成功率更高，但差异较小。在实际治疗环境中，治疗依从性是一个大问题，较短疗程可能会提高依从性，这些差异可能不明显。需要在项目条件下比较<6个月与6个月的治疗，以确定这一点。
